Insulin regulatory status
Current status of Insulin in the United States: FDA approved. In sport: WADA prohibited. Details, sources, and the dated timeline follow.
By the PeptideAgent Editorial Team. Draft, pending editorial review. Last verified
What is the current status of Insulin?
- FDA and compounding
- FDA approved in many forms: animal derived insulins from 1923, recombinant human insulin (Humulin) in 1982, insulin lispro in 1996, glargine in 2000, and subsequent analogs and biosimilars (which transitioned to biologic regulation in March 2020, enabling interchangeable products such as Semglee). Regular and NPH human insulin are available without a prescription in most states; analogs are prescription only. Insulin is not compounded and is not on any FDA bulks list.
- WADA
- WADA prohibited
- Access path
- Prescription from a licensed provider filled at a retail pharmacy; some human insulins are sold without a prescription in many states.
- Not available through compounding pharmacies or telehealth peptide clinics as a compounded product.
Full Insulin page: evidence, dosing in the literature, and sources
How has the status of Insulin changed over time?
- WADA
WADA publishes the 2027 Prohibited List
WADA published the 2027 Prohibited List on September 21, 2026, and it takes effect January 1, 2027. The S2 peptide hormone and growth factor classes are unchanged. BPC-157 is still named under S0, and MOTS-c is still named under S4.4 as an activator of AMP-activated protein kinase. WADA added a note that many peptides without approval for human use fall under S0 or another section, and that a peptide not named on the list may still be prohibited. GLP-1 receptor agonists such as semaglutide and tirzepatide are still not on the list.
- WADA
WADA 2026 Prohibited List takes effect
The 2026 WADA Prohibited List took effect on January 1, 2026 and continues to prohibit the S2 peptide hormone and growth factor classes (GHRH analogs, growth hormone secretagogues, GH fragments, IGF-1 and analogs, MGF, thymosin beta-4 and derivatives, hCG and GnRH-class releasing factors in males), myostatin inhibitors, insulin and the AMPK activator MOTS-c under S4, desmopressin under S5, and BPC-157 under S0. GLP-1 receptor agonists such as semaglutide and tirzepatide are not on the list.
- WADA
WADA 2025 Prohibited List keeps peptide hormones and growth factors banned at all times
The 2025 WADA Prohibited List took effect on January 1, 2025. Section S2 (peptide hormones, growth factors, related substances and mimetics) covers GHRH analogs such as CJC-1295, sermorelin, and tesamorelin, growth hormone secretagogues such as ipamorelin, GHRP-2, GHRP-6, hexarelin, and ibutamoren (MK-677), growth hormone fragments such as AOD-9604, growth factors including IGF-1 and its analogs, MGF, and thymosin beta-4 (TB-500), and chorionic gonadotropin and releasing factors such as gonadorelin and kisspeptin (prohibited in males). Myostatin inhibitors such as ACE-031 fall under S4, insulin under S4 metabolic modulators, desmopressin under S5, and BPC-157 remains an S0 non-approved substance.
Sources
Numbered citations in the answers above point here, followed by the regulatory sources on record for Insulin and the source of each dated event.
- [1]FDA prescribing information for Lantus (insulin glargine) injection, via DailyMedFDA, 2025
- [2]FDA prescribing information for Humulin R (insulin human) injection, via DailyMedFDA, 2026
- [3]WADA Prohibited List, section S4 hormone and metabolic modulators (insulins)WADA, 2026
- [4]WADA 2027 Prohibited ListWADA, 2026